Belgium's UCB says that the US Food and Drug Administration has granted paediatric exclusivity to its blockbuster epilepsy treatment Keppra, extended the exclusivity on its patent by six months.

The decision was based on paediatric data submitted to the FDA following a written request in 2001. A key patent on Keppra (levetiracetam) was set to expire next month, but the agency's decison extends the period of exclusivity on the drug across all licensed indications by six months to January 2009.

UCB also announced that the FDA has accepted for filing and six-month priority review the supplementary New Drug Application for Keppra as adjunctive treatment of partial onset seizures in infants and children with epilepsy, aged from one month to under four years. Chief medical officer Iris Loew-Friedrich added that the trials supporting this sNDA "included the third well-controlled trial of Keppra in a paediatric population, with studies in partial onset seizures now extending from infants to children and adolescents."

Levetiracetam was shown to significantly reduce the frequency of partial onset seizures with 43.1% of patients experiencing at least a 50% reduction in seizure frequency during the evaluation period (five days) compared with 19.6% of placebo-treated patients. It was generally well-tolerated and the most commonly reported adverse events that occurred more frequently in the treatment group were somnolence (13.3% vs 1.8% for placebo) and irritability (11.7% vs 0 for placebo).

In October 2007, UCB announced that it had reached an agreement to settle pending patent infringement lawsuits in the USA with Mylan, and subject to its receiving FDA approval, the latter will be allowed to sell its generic version of the drug effective November 1 this year, in advance of the expiry of UCB's market exclusivity on January 14, 2009.